# FDA 483 - Alvogen, Inc - September 11, 2020

Source: https://www.keypedia.com/records/483/alvogen-inc/4314b30c-4c7e-4790-860d-60ad10ae2d9b

> FDA 483 for Alvogen, Inc on September 11, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alvogen, Inc
- Inspection Date: 2020-09-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Alvogen, Inc. in Morristown, NJ, was cited for significant deficiencies in its adverse drug experience reporting system during an FDA inspection. The firm failed to develop written procedures for post-marketing surveillance, including social media, and submitted numerous serious and unexpected adverse drug experience reports, as well as periodic safety reports, significantly late to the FDA. These issues indicate a systemic failure in pharmacovigilance compliance.

## Related Documents

- [483 - 2021-06-10](https://www.keypedia.com/records/483/alvogen-inc/4c5dff3f-5a91-4cfa-9d81-935cfaa13575)

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.keypedia.com/companies/alvogen-inc/685658a8-f147-4c48-8874-4c6dcbd66bb8

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248